Advisory Commission on Childhood Vaccines; Notice of Meeting, 45583-45584 [2011-19274]
Download as PDF
<![CDATA[
Federal Register / Vol. 76, No. 146 / Friday, July 29, 2011 / Notices
45583
Department of Health and Human
Services and the Department of Justice
with regard to safety, efficacy, and abuse
potential, and risk management, risk
communication, and quantitative
evaluation of spontaneous reports, and
recommends actions to be taken by FDA
with regard to marketing, investigation,
and control of such drugs or other
substances.
drug products for use in the treatment
of neurologic diseases.
P. Psychopharmacologic Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the practice of
psychiatry and related fields.
J. Endocrinologic and Metabolic Drugs
Advisory Committee
Q. Pulmonary-Allergy Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of pulmonary disease and diseases with
allergic and/or immunologic
mechanisms.
and small businesses are adequately
represented on its advisory committees,
and therefore, encourages nominations
for appropriately qualified candidates
from these groups. Specifically, in this
document, nominations for nonvoting
representatives of industry interests are
encouraged from the drug
manufacturing industry.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: July 22, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of endocrine and metabolic disorders.
K. Gastrointestinal Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of gastrointestinal disorders.
L. Medical Imaging Drugs Advisory
Committee
The Committee reviews and evaluates
data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in diagnostic and therapeutic
procedures using radioactive
pharmaceuticals and contrast media
used in diagnostic radiology. Elsewhere
in this issue of the Federal Register,
FDA is issuing a final rule adding the
Medical Imaging Drugs Advisory
Committee to the list of FDA standing
advisory committees in 21 CFR 14.100,
as well as a request for nominations of
voting members and a request for
nominations of voting and nonvoting
consumer representative members.
M. Nonprescription Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of over-the-counter (nonprescription)
human drug products for use in the
treatment of a broad spectrum of human
symptoms and diseases.
mstockstill on DSK4VPTVN1PROD with NOTICES
N. Oncologic Drugs Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of cancer.
O. Peripheral and Central Nervous
System Drugs Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
VerDate Mar<15>2010
16:17 Jul 28, 2011
Jkt 223001
II. Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see FOR FURTHER INFORMATION
CONTACT) within 30 days of publication
of this document (see DATES). Within the
subsequent 30 days, FDA will send a
letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for a particular committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner will select the nonvoting
member to represent industry interests.
III. Application Procedure
Individuals may self nominate and/or
an organization may nominate one or
more individuals to serve as a nonvoting
industry representative. A current
curriculum vitae and the name of the
committee of interest should be sent to
the FDA contact person (see FOR
FURTHER INFORMATION CONTACT) within
30 days (see DATES). FDA will forward
all nominations to the organizations
expressing interest in participating in
the selection process for the committee.
(Persons who nominate themselves as
nonvoting industry representatives will
not participate in the selection process.)
FDA has a special interest in ensuring
that women, minority groups,
individuals with physical disabilities,
PO 00000
Frm 00080
Fmt 4703
Sfmt 4703
[FR Doc. 2011–19065 Filed 7–28–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Commission on Childhood
Vaccines; Notice of Meeting
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: Advisory Commission on
Childhood Vaccines (ACCV).
Date and Time: September 1, 2011,
1 p.m. to 5 p.m. EDT, September 2,
2011, 9 a.m. to 12 p.m. EDT.
Place: Parklawn Building (and via
audio conference call), Conference
Room 10–65, 5600 Fishers Lane,
Rockville, MD 20857.
The ACCV will meet on Thursday,
September 1 from 1 pm to 5 pm (EDT)
and on Friday, September 2 from 9 a.m.
to 12 p.m. (EDT). The public can join
the meeting via audio conference call by
dialing 1–800–369–3104 on September
1 and 2 and providing the following
information:
Leader’s Name: Dr. Geoffrey Evans.
Password: ACCV.
Agenda: The agenda items for the
September meeting will include, but are
not limited to: updates from the
Division of Vaccine Injury
Compensation (DVIC), Department of
Justice (DOJ), National Vaccine Program
Office (NVPO), Immunization Safety
Office (Centers for Disease Control and
Prevention), National Institute of
Allergy and Infectious Diseases
(National Institutes of Health) and
Center for Biologics, Evaluation and
Research (Food and Drug
Administration). A draft agenda and
additional meeting materials will be
posted on the ACCV Web site (https://
E:\FR\FM\29JYN1.SGM
29JYN1
45584
Federal Register / Vol. 76, No. 146 / Friday, July 29, 2011 / Notices
www.hrsa.gov/vaccinecompensation/
accv.htm) prior to the meeting. Agenda
items are subject to change as priorities
dictate.
Public Comment: Persons interested
in attending the meeting in person or
providing an oral presentation should
submit a written request, along with a
copy of their presentation to: Annie
Herzog, DVIC, Healthcare Systems
Bureau (HSB), Health Resources and
Services Administration (HRSA), Room
11C–26, 5600 Fishers Lane, Rockville,
Maryland 20857 or e-mail: aherzog
@hrsa.gov. Requests should contain the
name, address, telephone number, email address, and any business or
professional affiliation of the person
desiring to make an oral presentation.
Groups having similar interests are
requested to combine their comments
and present them through a single
representative. The allocation of time
may be adjusted to accommodate the
level of expressed interest. DVIC will
notify each presenter by e-mail, mail or
telephone of their assigned presentation
time. Persons who do not file an
advance request for a presentation, but
desire to make an oral statement, may
announce it at the time of the public
comment period. Public participation
and ability to comment will be limited
to space and time as it permits.
FOR FURTHER INFORMATION CONTACT:
Anyone requiring information regarding
the ACCV should contact Annie Herzog,
DVIC, HSB, HRSA, Room 11C–26, 5600
Fishers Lane, Rockville, MD 20857;
telephone (301) 443–6593 or e-mail:
aherzog@hrsa.gov.
Dated: July 26, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
Statement of Organization, Functions
and Delegations of Authority
This notice amends Part R of the
Statement of Organization, Functions
and Delegations of Authority of the
Department of Health and Human
Services (HHS), Health Resources and
Services Administration (HRSA) (60 FR
56605, as amended November 6, 1995;
as last amended at 76 FR 18560–18561
dated April 4, 2011).
This notice reflects organizational
changes in the Health Resources and
16:17 Jul 28, 2011
Jkt 223001
Chapter RM—Maternal and Child
Health Bureau
Section RM–10, Organization
Delete in its entirety and replace with
the following:
The Office of the Associate
Administrator (RM) is headed by the
Associate Administrator, Maternal and
Child Health Bureau (MCHB), who
reports directly to the Administrator,
Health Resources and Services
Administration. MCHB includes the
following components:
(1) Office of the Associate
Administrator (RM);
(2) Office of Operations and
Management (RM1);
(3) Division of Services for Children
with Special Health Needs (RM2);
(4) Division of Child, Adolescent and
Family Health (RM3);
(5) Division of Research, Training and
Education (RM4);
(6) Division of Healthy Start and
Perinatal Services (RM5);
(7) Division of State and Community
Health (RM6);
(8) Office of Epidemiology, Policy and
Evaluation (RM7); and
(9) Division of Home Visiting and
Early Childhood Systems (RM8).
Section RM–20, Functions
[FR Doc. 2011–19274 Filed 7–28–11; 8:45 am]
VerDate Mar<15>2010
Services Administration. Specifically,
this notice updates the functional
statement for the Maternal and Child
Health Bureau (RM) by creating the
Division of Home Visiting and Early
Childhood Systems (RM8); and moving
the Home Visiting function from the
Division of Child, Adolescent and
Family Health (RM3) to the Division of
Home Visiting and Early Childhood
Systems (RM8).
(1) Delete the functional statement for
the Division of Child, Adolescent and
Family Health (RM3) and replace in its
entirety; (2) establish the Division of
Home Visiting and Early Childhood
Systems (RM8); and (3) move the Home
Visiting function from the Division of
Child, Adolescent and Family Health
(RM3) to the newly established Division
of Home Visiting and Early Childhood
Systems (RM8).
Division of Child, Adolescent, and
Family Health (RM3)
The Division of Child, Adolescent,
and Family Health provides national
leadership in planning, directing,
coordinating, monitoring, and
evaluating national programs focusing
on the promotion of health and
prevention of disease and injury among
children, adolescents, young adults and
their families with special emphasis on
PO 00000
Frm 00081
Fmt 4703
Sfmt 4703
the development and implementation of
family-centered, comprehensive,
coordinated, community-based and
culturally competent systems of care for
such populations. Specifically, the
Division: (1) Administers a program
which supports the development of
systems of care and services for
children, adolescents, young adults and
their families; (2) develops policies and
guidelines and promulgates standards
for professional services and effective
organization and administration of
health programs for children,
adolescents, young adults and their
families; (3) accounts for the
administration of funds and other
resources for grants, contracts, and
programmatic consultation and
assistance; (4) coordinates with MCHB
Divisions and Offices in promoting
program objectives and the mission of
the Bureau; (5) serves as the focal point
within the Bureau in implementing
programmatic statutory requirements for
State programs for children,
adolescents, young adults and their
families; (6) provides consultation and
technical assistance to State programs
for children, adolescents, young adults
and their families and to local
communities, consistent with a Bureauwide technical assistance consultation
plan, working with other agencies and
organizations; (7) provides liaison with
public, private, professional and
voluntary organizations on programs
designed to improve services for
children, adolescents, young adults and
their families; (8) carries out a national
program supporting Child Death Review
systems; (9) carries out a national
program on school health activities; (10)
carries out a national program designed
to improve the provision of emergency
medical services for children; (11)
carries out a national program designed
to improve the provision of oral health
services for children; (12) carries out a
national program on injury prevention
for children and adolescents; (13)
coordinates within this Agency and
with other Federal programs
(particularly Title XIX of the Social
Security Act) to extend and improve
comprehensive, coordinated services
and promote integrated State-based
systems of care for children,
adolescents, young adults and their
families; (14) disseminates information
on preventive health services and
advances in the care and treatment of
children, adolescents, young adults and
their families; (15) participates in the
development of strategic plans,
regulatory activities, policy papers,
legislative proposals, and budget
submissions relating to health services
E:\FR\FM\29JYN1.SGM
29JYN1
]]>Agencies
[Federal Register Volume 76, Number 146 (Friday, July 29, 2011)]
[Notices]
[Pages 45583-45584]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19274]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Advisory Commission on Childhood Vaccines; Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), notice is hereby given of the following
meeting:
Name: Advisory Commission on Childhood Vaccines (ACCV).
Date and Time: September 1, 2011, 1 p.m. to 5 p.m. EDT, September
2, 2011, 9 a.m. to 12 p.m. EDT.
Place: Parklawn Building (and via audio conference call),
Conference Room 10-65, 5600 Fishers Lane, Rockville, MD 20857.
The ACCV will meet on Thursday, September 1 from 1 pm to 5 pm (EDT)
and on Friday, September 2 from 9 a.m. to 12 p.m. (EDT). The public can
join the meeting via audio conference call by dialing 1-800-369-3104 on
September 1 and 2 and providing the following information:
Leader's Name: Dr. Geoffrey Evans.
Password: ACCV.
Agenda: The agenda items for the September meeting will include,
but are not limited to: updates from the Division of Vaccine Injury
Compensation (DVIC), Department of Justice (DOJ), National Vaccine
Program Office (NVPO), Immunization Safety Office (Centers for Disease
Control and Prevention), National Institute of Allergy and Infectious
Diseases (National Institutes of Health) and Center for Biologics,
Evaluation and Research (Food and Drug Administration). A draft agenda
and additional meeting materials will be posted on the ACCV Web site
(https://
[[Page 45584]]
www.hrsa.gov/vaccinecompensation/accv.htm) prior to the meeting. Agenda
items are subject to change as priorities dictate.
Public Comment: Persons interested in attending the meeting in
person or providing an oral presentation should submit a written
request, along with a copy of their presentation to: Annie Herzog,
DVIC, Healthcare Systems Bureau (HSB), Health Resources and Services
Administration (HRSA), Room 11C-26, 5600 Fishers Lane, Rockville,
Maryland 20857 or e-mail: aherzog@hrsa.gov. Requests should contain the
name, address, telephone number, e-mail address, and any business or
professional affiliation of the person desiring to make an oral
presentation. Groups having similar interests are requested to combine
their comments and present them through a single representative. The
allocation of time may be adjusted to accommodate the level of
expressed interest. DVIC will notify each presenter by e-mail, mail or
telephone of their assigned presentation time. Persons who do not file
an advance request for a presentation, but desire to make an oral
statement, may announce it at the time of the public comment period.
Public participation and ability to comment will be limited to space
and time as it permits.
FOR FURTHER INFORMATION CONTACT: Anyone requiring information regarding
the ACCV should contact Annie Herzog, DVIC, HSB, HRSA, Room 11C-26,
5600 Fishers Lane, Rockville, MD 20857; telephone (301) 443-6593 or e-
mail: aherzog@hrsa.gov.
Dated: July 26, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-19274 Filed 7-28-11; 8:45 am]
BILLING CODE 4165-15-P
